The imaging agent, called Amyvid, is scheduled for commercial launch on June 1, according to a statement from Dublin, Ohio-based Cardinal. Amyvid was approved by the U.S. Food and Drug Administration in April.
Amyvid binds to beta amyloid plaques, which are characteristic of Alzheimer’s and other neurological conditions, and appears in PET scan images of the brain. It could help doctors diagnose Alzheimer’s earlier.
But Amyvid has a major drawback, as Forbes’ Matthew Herper noted after it was approved: A positive result doesn’t confirm that a patient has Alzheimer’s or any other cognitive disorder, so the test will be used primarily to confirm that a patient does not have Alzheimer’s.
“It’s unlikely that the drug will be used as an important diagnostic in the near term,” Herper said.
Amyvid is intended to be used as an “adjunct” to other diagnostic tools, according to the statement from Cardinal.
It’s also an open question as to how clinically useful Lilly’s Alzheimer’s test will be. In a 59-patient study in which a patient’s Alzheimer’s status was later determined by autopsy, all Amyvid readers got at least 5 percent and up to 14 percent of diagnoses wrong, Herper notes.
Cardinal will manufacture the drug at seven sites, with the potential to expand to 12 by the end of the year.
Amyvid was developed by Avid Radiopharmaceuticals, which Lilly acquired for $300 million in 2010. In March 2011, the FDA declined to approve Amyvid and told Lilly it needed to establish a training program to help make sure scans that use Amyvid would be interpreted properly.
The Alzheimer’s imaging agent was named Cleveland Clinic’s top medical innovation for 2011.
Lilly beat several other companies to market with a radioactive beta amyloid imaging agent, including Navidea Biopharmaceuticals, which licensed its imaging agent from AstraZeneca last year; Bayer AG and GE Healthcare.